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Tuesday, August 26, 2014

As the current Ebola outbreak grows more dire in West Africa, a greater urgency has been placed on efforts underway locally to develop a commercial test to rapidly detect the onset of the deadly virus.

However, it's too soon to tell how much the work being done by Corgenix Medical Corp. could be accelerated, officials for the Broomfield-based diagnostics products maker said Monday.

In late June, Corgenix Medical Corp. was awarded a $2.9 million grant from the National Institutes of Health to further develop a prototype diagnostic test for the Ebola virus. The project's timeline is three years.

The deaths attributed to the Ebola outbreak in West Africa climbed to 1,013 on Monday, according to the World Health Organization.

Corgenix has commenced work under the grant, but it is premature to say whether the company would be able to accelerate that work and shave a couple months or a year off that three-year timetable, Simpson said.

"We'll try to accelerate this if we can," he said. "It takes a bit of time."

Corgenix, founded in 1990, develops a variety of diagnostic products that range from tests to determine aspirin's effectiveness in individual humans to assays that can rapidly detect viral hemorrhagic fevers such as Lassa.

The work on a Lassa diagnostic test — which resulted in Corgenix's ReLASV Antigen Rapid Test gaining a CE Mark, allowing for sale in the European Union — has made for an easier roadmap for the Ebola test, Simpson said.

"There are different antibodies, and it's detecting a different virus, but we're building on the knowledge we established under Lassa," he said. " ... I see no indication that it's not going to be successful. We're using the same model for Lassa products, and they're very effective."

The Ebola test resulted from a 2010 to 2012 research program conducted in partnership with the Viral Hemorrhagic Fever Consortium and funded with nearly $600,000 from the NIH.

Corgenix officials have said the Ebola assay identified potential indications of the deadly virus in 15 minutes after an initial screening and confirmed the diagnosis in a little more than an hour. Other testing methods can take a few hours.

The rapid test for Ebola has not been cleared or approved by any worldwide agency.

The latest $2.9 million grant is designed to take the test to a point where it could be commercialized, Simpson said.

The initial work on the tests will take place in Broomfield and in Viral Hemorrhagic Fever Consortium partner labs in places such as Galveston, Texas. The tests locally do not involve any live samples of the virus

The latter end of the work would involve additional research and testing in the areas where Ebola is endemic, he said.

Earlier this year, Corgenix shipped out hundreds of its prototype Ebola rapid tests as part of a "first line of defense" attempt to detect the virus in a matter of minutes.

Those prototype test supplies have since been exhausted and are no longer in use in the "hot zone" areas.

"Because of the severity of the outbreak, they shifted from screening," Simpson said. "Now anyone who shows symptoms (is brought in for medical care)."

No Corgenix officials are operating out of West Africa, although some other researchers within the Viral Hemorrhagic Fever Consortium remain in the area, he said.

"The people over there right now are MDs and they're just trying to help in the overall epidemic control; the research is really postponed," Simpson said. "We've got to take care of the people first. What we expect is once they get it cleaned up, it'll get back to business as usual."